ID

37843

Beskrivning

Study ID: 111634 Clinical Study ID: 111634 Study Title: A phase III, open, controlled study in South Africa to assess the immunogenicity, safety and reactogenicity of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine administered as a 3-dose (6, 10, 14 weeks) primary immunization course in HIV infected infants, HIV exposed uninfected infants and HIV unexposed uninfected infants followed by a booster vaccination at 9-10 months of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00829010 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Pneumococcal vaccine GSK1024850A Trade Name: Tritanrix-HepB/Hib, Rotarix Study Indication: Infections, Streptococcal This phase III trial studies the immunogenicity, safety and reactogenicity of a 10-valent pneumococcal conjugate vaccine in three groups of infants that differ by HIV status: HIV-positive infants, HIV-negative infants who are exposed to the virus (by their HIV-positive mother), and HIV-negative infants who are not exposed. The study consists of Screening at 4-8 weeks of age (only for HIV-positive and HIV-exposed infants without HIV-DNA test) and 10 subsequent Visits over a period of 23 months. There are five study cohorts: HIV-positive and HIV-exposed participants receive the vaccine at Visits 1, 2, 3 (i.e. 6, 10 and 14 weeks of life; primary course) and 5 (9-10 months of age; booster), whereas HIV-negative, unexposed infants are randomly assigned to one of three vaccination schedules: the aforementioned schedule consisting of the primary course and the booster, or the 3-dose primary course only without the booster vaccination, or a different primary course consisting of only two vaccinations at Visits 1 and 3 (6 and 14 weeks of age) followed by a booster at Visit 5 (9-10 months). Visit 1 is scheduled at 6-10 weeks of life. The interval between Visits 1 and 2, 2 and 3, as well as 3 and 4 has to be 28-42 days each. Visit 5 then takes place at 9-10 months of age. The interval between Visit 5 and 6 again has to be 28-42 days. Visit 7 is scheduled at 12-13 months of age, Visit 8 at 15-18 months, Visit 9 at 16-19 months, and the final Visit 10 is performed when the subjects are 24-27 months old. This form contains the study's Inclusion/Exclusion Criteria and is to be filled in at Visit 1.

Nyckelord

Versioner (1)
  1. 2019-08-27 2019-08-27 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

27 augusti 2019

DOI

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Creative Commons BY-NC 3.0
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10-valent pneumococcal vaccine in HIV-positive, HIV-exposed and HIV-negative infants - NCT00829010

Engelsk

Eligibility Criteria

1 Formulär  
  1. StudyEvent: ODM
    1. Eligibility Criteria
Administrative data
Beskrivning

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beskrivning

Clinical Trial Subject Unique Identifier

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Cohort
Beskrivning

Cohort

Datatyp

integer

Alias
UMLS CUI [1]
C0599755
Date of Visit
Beskrivning

Date of Visit

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Eligibility check
Beskrivning

Eligibility check

Alias
UMLS CUI-1
C1516637
Did the subject meet all the entry criteria?
Beskrivning

If No, fill in all items below corresponding to violations of any inclusion/exclusion criteria. Do not enter the subject into the study if he/she failed any inclusion or exclusion criteria below.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C1550543
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Male or female subjects between, and including 6-10 weeks (42-76 days) of age at the time of the first vaccination.
Beskrivning

Gender and age at first vaccination

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0001779
UMLS CUI [2,2]
C0205435
UMLS CUI [2,3]
C0042196
Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol (e.g. return for vaccination and follow-up visits).
Beskrivning

Parents/guardians protocol compliance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0030551
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C1274041
Written informed consent obtained from the parent(s)/guardian(s) of the child
Beskrivning

informed consent obtained from the parent(s)/guardian(s)

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0030551
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1274041
Free of any known or suspected health problems (as established by medical history and clinical examination before entering into the study), that would contraindicate the initiation of routine immunizations outside a clinical trial context.
Beskrivning

No known/suspected health problems contraindicating immunizations, by medical history and examination

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332296
UMLS CUI [1,2]
C0750491
UMLS CUI [1,3]
C1446390
UMLS CUI [1,4]
C1301624
UMLS CUI [1,5]
C0020971
UMLS CUI [2,1]
C0332296
UMLS CUI [2,2]
C0205309
UMLS CUI [2,3]
C1446390
UMLS CUI [2,4]
C1301624
UMLS CUI [2,5]
C0020971
UMLS CUI [3]
C0262926
UMLS CUI [4]
C0031809
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of the study vaccines, or planned use during the study period.
Beskrivning

Recent or planned use of any other investigational or non-registered product

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0347984
UMLS CUI [1,4]
C2347804
UMLS CUI [2,1]
C1524063
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C0332185
A family history of hereditary immunodeficiency other than HIV infection
Beskrivning

family history of hereditary immunodeficiency other than HIV infection

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0241889
UMLS CUI [1,2]
C0439660
UMLS CUI [1,3]
C0021051
UMLS CUI [1,4]
C1705847
UMLS CUI [1,5]
C0019693
Major congenital defects or serious chronic illness other than HIV infection
Beskrivning

Applicable only for subjects who have been enrolled using the initial ICF

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0000768
UMLS CUI [1,2]
C0205164
UMLS CUI [2,1]
C0008679
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C1705847
UMLS CUI [2,4]
C0019693
Moderately and severely symptomatic: stages III and IV according to latest version of the WHO classification
Beskrivning

For HIV infected infants

Datatyp

boolean

Alias
UMLS CUI [1]
C1976611
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period
Beskrivning

Administration of immunoglobulins and/or blood products, since birth or planned during study

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0021027
UMLS CUI [1,3]
C0262926
UMLS CUI [2,1]
C1533734
UMLS CUI [2,2]
C0021027
UMLS CUI [2,3]
C1301732
UMLS CUI [2,4]
C0347984
UMLS CUI [2,5]
C2347804
UMLS CUI [3,1]
C0371802
UMLS CUI [3,2]
C0262926
UMLS CUI [4,1]
C0371802
UMLS CUI [4,2]
C1301732
UMLS CUI [4,3]
C0347984
UMLS CUI [4,4]
C2347804
Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae type b, rotavirus and/or Streptococcus pneumoniae
Beskrivning

The exclusion criteria concerning the previous vaccination against rotavirus is applicable only for subjects who have been enrolled during the Amendment 1/ Amendment 2 ICF

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0205156
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0012546
UMLS CUI [2,1]
C0205156
UMLS CUI [2,2]
C0042196
UMLS CUI [2,3]
C0039614
UMLS CUI [3,1]
C0205156
UMLS CUI [3,2]
C0042196
UMLS CUI [3,3]
C0043167
UMLS CUI [4,1]
C0205156
UMLS CUI [4,2]
C0042196
UMLS CUI [4,3]
C0121772
UMLS CUI [5,1]
C0205156
UMLS CUI [5,2]
C0042196
UMLS CUI [5,3]
C0038410
UMLS CUI [6,1]
C0205156
UMLS CUI [6,2]
C0042196
UMLS CUI [6,3]
C0597418
History of, or intercurrent, diphtheria, tetanus, pertussis, and Haemophilus influenzae type b disease
Beskrivning

History of, or intercurrent, diphtheria, tetanus, pertussis, and Haemophilus influenzae type b disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0012546
UMLS CUI [2,1]
C0277557
UMLS CUI [2,2]
C0012546
UMLS CUI [3,1]
C0262926
UMLS CUI [3,2]
C0039614
UMLS CUI [4,1]
C0277557
UMLS CUI [4,2]
C0039614
UMLS CUI [5,1]
C0262926
UMLS CUI [5,2]
C0043167
UMLS CUI [6,1]
C0277557
UMLS CUI [6,2]
C0043167
UMLS CUI [7,1]
C0262926
UMLS CUI [7,2]
C0121772
UMLS CUI [8,1]
C0277557
UMLS CUI [8,2]
C0121772
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines
Beskrivning

allergic disease or reactions likely to be exacerbated by any component of the vaccines

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2106654
UMLS CUI [1,2]
C0750492
UMLS CUI [1,3]
C4086268
UMLS CUI [1,4]
C1705248
UMLS CUI [1,5]
C0042210
History of any neurological disorders or seizures
Beskrivning

Applicable only for subjects who have been enrolled using the initial ICF

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0027765
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0036572
Acute disease at the time of enrolment
Beskrivning

Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea or mild upper respiratory infection, provided the body temperature is <38°C (rectal measurement) or <37.5°C (for oral/axi llary/tympanic measurements). Study entry should be delayed until the illness has improved.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0001314
UMLS CUI [1,2]
C0521116
Babies for which weight for age is < 3rd percentile at Visit 1, using standard growth charts
Beskrivning

From approval of protocol amendment II, the exclusion criterion will be modified as follow: Babies whose weight for age is < 3rd percentile at Visit 1, using standard growth charts, with the exception of HIV infected infants for which the decision of enrolment is left to the investigator’s discretion. (Amended 29 June 2009)

Datatyp

boolean

Alias
UMLS CUI [1]
C0517416
Gastroenteritis within 7 days preceding the study vaccine administration
Beskrivning

warrants deferral of the vaccination Applicable only for subjects who have been enrolled using the Amendment 1 / Amendment2 ICF

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0017160
UMLS CUI [1,2]
C0332185
Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal (GI) tract, intussusception (IS) or other medical condition determined to be serious by the investigator
Beskrivning

Applicable only for subjects who have been enrolled using the Amendment 1 / Amendment2 ICF

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0750502
UMLS CUI [1,2]
C0262926
UMLS CUI [1,3]
C0017178
UMLS CUI [1,4]
C0008679
UMLS CUI [2,1]
C0017189
UMLS CUI [2,2]
C0000768
UMLS CUI [2,3]
C4072785
UMLS CUI [3]
C0021933
UMLS CUI [4,1]
C0205394
UMLS CUI [4,2]
C0009488
UMLS CUI [4,3]
C0205082
UMLS CUI [4,4]
C0008961
UMLS CUI [4,5]
C0022423
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Similar models

Eligibility Criteria

1 Formulär
  1. StudyEvent: ODM
    1. Eligibility Criteria
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item
Cohort
integer
C0599755 (UMLS CUI [1])
Cohort
Code List
Cohort
CL Item
HIV-pos. (1)
CL Item
HIV-neg. exposed (2)
CL Item
HIV-neg. unexposed, 3+1 schedule (3)
CL Item
HIV-neg. unexposed, 3+0 schedule (4)
CL Item
HIV-neg. unexposed, 2+1 schedule (5)
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item Group
Eligibility check
C1516637 (UMLS CUI-1)
Entry criteria fulfilled?
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Gender and age at first vaccination
Item
Male or female subjects between, and including 6-10 weeks (42-76 days) of age at the time of the first vaccination.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2,1])
C0205435 (UMLS CUI [2,2])
C0042196 (UMLS CUI [2,3])
Parents/guardians protocol compliance
Item
Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol (e.g. return for vaccination and follow-up visits).
boolean
C0525058 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C1274041 (UMLS CUI [2,2])
informed consent obtained from the parent(s)/guardian(s)
Item
Written informed consent obtained from the parent(s)/guardian(s) of the child
boolean
C0021430 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1274041 (UMLS CUI [2,2])
No known/suspected health problems contraindicating immunizations, by medical history and examination
Item
Free of any known or suspected health problems (as established by medical history and clinical examination before entering into the study), that would contraindicate the initiation of routine immunizations outside a clinical trial context.
boolean
C0332296 (UMLS CUI [1,1])
C0750491 (UMLS CUI [1,2])
C1446390 (UMLS CUI [1,3])
C1301624 (UMLS CUI [1,4])
C0020971 (UMLS CUI [1,5])
C0332296 (UMLS CUI [2,1])
C0205309 (UMLS CUI [2,2])
C1446390 (UMLS CUI [2,3])
C1301624 (UMLS CUI [2,4])
C0020971 (UMLS CUI [2,5])
C0262926 (UMLS CUI [3])
C0031809 (UMLS CUI [4])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Recent or planned use of any other investigational or non-registered product
Item
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of the study vaccines, or planned use during the study period.
boolean
C1524063 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C2347804 (UMLS CUI [1,4])
C1524063 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0332185 (UMLS CUI [2,3])
family history of hereditary immunodeficiency other than HIV infection
Item
A family history of hereditary immunodeficiency other than HIV infection
boolean
C0241889 (UMLS CUI [1,1])
C0439660 (UMLS CUI [1,2])
C0021051 (UMLS CUI [1,3])
C1705847 (UMLS CUI [1,4])
C0019693 (UMLS CUI [1,5])
Major congenital defects or serious chronic illness other than HIV infection
Item
Major congenital defects or serious chronic illness other than HIV infection
boolean
C0000768 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0008679 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C1705847 (UMLS CUI [2,3])
C0019693 (UMLS CUI [2,4])
WHO HIV staging
Item
Moderately and severely symptomatic: stages III and IV according to latest version of the WHO classification
boolean
C1976611 (UMLS CUI [1])
Administration of immunoglobulins and/or blood products, since birth or planned during study
Item
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period
boolean
C1533734 (UMLS CUI [1,1])
C0021027 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
C1533734 (UMLS CUI [2,1])
C0021027 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
C0347984 (UMLS CUI [2,4])
C2347804 (UMLS CUI [2,5])
C0371802 (UMLS CUI [3,1])
C0262926 (UMLS CUI [3,2])
C0371802 (UMLS CUI [4,1])
C1301732 (UMLS CUI [4,2])
C0347984 (UMLS CUI [4,3])
C2347804 (UMLS CUI [4,4])
Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae type b, rotavirus and/or Streptococcus pneumoniae
Item
Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae type b, rotavirus and/or Streptococcus pneumoniae
boolean
C0205156 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0012546 (UMLS CUI [1,3])
C0205156 (UMLS CUI [2,1])
C0042196 (UMLS CUI [2,2])
C0039614 (UMLS CUI [2,3])
C0205156 (UMLS CUI [3,1])
C0042196 (UMLS CUI [3,2])
C0043167 (UMLS CUI [3,3])
C0205156 (UMLS CUI [4,1])
C0042196 (UMLS CUI [4,2])
C0121772 (UMLS CUI [4,3])
C0205156 (UMLS CUI [5,1])
C0042196 (UMLS CUI [5,2])
C0038410 (UMLS CUI [5,3])
C0205156 (UMLS CUI [6,1])
C0042196 (UMLS CUI [6,2])
C0597418 (UMLS CUI [6,3])
History of, or intercurrent, diphtheria, tetanus, pertussis, and Haemophilus influenzae type b disease
Item
History of, or intercurrent, diphtheria, tetanus, pertussis, and Haemophilus influenzae type b disease
boolean
C0262926 (UMLS CUI [1,1])
C0012546 (UMLS CUI [1,2])
C0277557 (UMLS CUI [2,1])
C0012546 (UMLS CUI [2,2])
C0262926 (UMLS CUI [3,1])
C0039614 (UMLS CUI [3,2])
C0277557 (UMLS CUI [4,1])
C0039614 (UMLS CUI [4,2])
C0262926 (UMLS CUI [5,1])
C0043167 (UMLS CUI [5,2])
C0277557 (UMLS CUI [6,1])
C0043167 (UMLS CUI [6,2])
C0262926 (UMLS CUI [7,1])
C0121772 (UMLS CUI [7,2])
C0277557 (UMLS CUI [8,1])
C0121772 (UMLS CUI [8,2])
allergic disease or reactions likely to be exacerbated by any component of the vaccines
Item
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines
boolean
C2106654 (UMLS CUI [1,1])
C0750492 (UMLS CUI [1,2])
C4086268 (UMLS CUI [1,3])
C1705248 (UMLS CUI [1,4])
C0042210 (UMLS CUI [1,5])
History of any neurological disorders or seizures
Item
History of any neurological disorders or seizures
boolean
C0262926 (UMLS CUI [1,1])
C0027765 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0036572 (UMLS CUI [2,2])
Acute disease at the time of enrolment
Item
Acute disease at the time of enrolment
boolean
C0001314 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
Weight for age by percentile
Item
Babies for which weight for age is < 3rd percentile at Visit 1, using standard growth charts
boolean
C0517416 (UMLS CUI [1])
Recent gastroenteritis
Item
Gastroenteritis within 7 days preceding the study vaccine administration
boolean
C0017160 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal (GI) tract, intussusception (IS) or other medical condition determined to be serious by the investigator
Item
Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal (GI) tract, intussusception (IS) or other medical condition determined to be serious by the investigator
boolean
C0750502 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0017178 (UMLS CUI [1,3])
C0008679 (UMLS CUI [1,4])
C0017189 (UMLS CUI [2,1])
C0000768 (UMLS CUI [2,2])
C4072785 (UMLS CUI [2,3])
C0021933 (UMLS CUI [3])
C0205394 (UMLS CUI [4,1])
C0009488 (UMLS CUI [4,2])
C0205082 (UMLS CUI [4,3])
C0008961 (UMLS CUI [4,4])
C0022423 (UMLS CUI [4,5])
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